Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers
NCT02222506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2016-09-05
Summary
The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with diabetic foot ulcers.
Conditions
- Diabetic Foot Ulcers
Interventions
- DEVICE
-
KLOX BioPhotonic System
KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 24 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for diabetic foot ulcers.
Sponsors & Collaborators
-
KLOX Technologies Inc.
lead INDUSTRY
Principal Investigators
-
Andreas Nikolis, Dr · Victoria Park MediSpa
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2016-02-29
Countries
- Canada
Study Locations
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